Prolotherapy for the Treatment of Chronic Lateral Epicondylitis

NCT00674622 | Completed Phase 2 Results DMC

• 1 other identifier: 1R21AT003969-01A1
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

Lateral epicondylitis (LE), or tennis elbow, is a common and often disabling condition affecting young and middle-aged adults-most commonly manual workers and recreational athletes. It results in significant pain and disability, limiting work productivity and an individual's ability to participate in and enjoy recreational activities. Like many other chronic musculoskeletal conditions LE often shows an incomplete response to acute treatments, leading to chronic pain and disability. Prolotherapy (PrT) involves the injection of an irritant or proliferant solution into tendons, ligaments, and joints to treat chronic musculoskeletal pain. We will be conducting a 3-group randomized, blinded trial to determine the safety and efficacy of PrT injections in the treatment of chronic LE. Additionally, we will seek to determine to what extent any beneficial effect of PrT is derived from deep needle placement vs. a specific effect of the injectate. The specific aims for this study are: 1) to determine if PrT is a safe, well-tolerated, and effective treatment for individuals with chronic LE; and 2) to determine whether the deep needle placement alone is responsible for the therapeutic effect, independent of injectate. In order to accomplish these aims, we will measure indicators of pain and disability using self-rating scales, questionnaires and physical measures. Subjects will be stratified prior to randomization on two factors: 1) unilateral vs. bilateral LE; and 2) treatment with steroids within the prior 6 months. If effective, subjects receiving PrT will show greater reduction of pain and functional impairment compared with the other two groups. This research will guide future studies on prolotherapy by determining what may be the best control condition. Additionally, further studies may explore the mechanism responsible for any beneficial effect.

Conditions

Lateral Epicondylitis; Tennis Elbow

Keywords

Lateral epicondylitis; Tennis elbow; Prolotherapy

Outcome Measures

Primary Outcomes (1)

• McGill Pain Questionnaire

  This is a pain severity rating. 15 adjectival descriptors of pain are scored on a 0-3 scale for a total score of 0-45 with a high score reflecting greater pain severity.

  6 weeks and 12 weeks post intervention

Secondary Outcomes (4)

• QuickDASH

  6 weeks and 12 weeks post-intervention

• Grip Strength

  6 weeks and 12 weeks post-intervention

• Nirschl Pain Phase Scale

  6 and 12 weeks post-intervention

• Pain Threshold on Dolorimetry

  6 and 12 weeks post-intervention

Study Arms (3)

Group 1-Prolotherapy

EXPERIMENTAL

Deep injection with 15% dextrose in lidocaine

Drug: Prolotherapy

Group 2-Deep Saline/Lidocaine

PLACEBO COMPARATOR

Deep injection with saline/lidocaine

Procedure: Placebo

Group 3-Superficial Saline/lidocaine

PLACEBO COMPARATOR

Superficial injection with saline/lidocaine

Procedure: Placebo

Interventions

Prolotherapy DRUG

Injection of 15% dextrose with lidocaine at the lateral epicondyle

Group 1-Prolotherapy

Placebo PROCEDURE

Saline/lidocaine

Group 2-Deep Saline/Lidocaine; Group 3-Superficial Saline/lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-65, as younger individuals are more likely to have other developmental conditions and older individuals are more likely to have a significant arthritic component to their elbow pain;
• Ability to speak, read, and write English;
• Unilateral or bilateral lateral elbow pain associated with findings on exam consistent with LE and absence of other conditions that can mimic LE such as radial tunnel syndrome.
• Functional impairment, due to the diagnosis of LE, with a Nirschl Pain Phase Scale (NPPS) rating of Phase 4 or higher.

You may not qualify if:

• Other conditions that result in significant impairment in upper extremity function such as fibromyalgia, rotator cuff tendonitis, cervical radiculopathy, or carpal tunnel syndrome;
• Prior surgery of the involved elbow;
• Known allergy to lidocaine or dextrose;
• Presence of an autoimmune condition such as rheumatoid arthritis, given that a possible immune mechanism is hypothesized for PrT.
• Presence of known immune dysfunction, such as with HIV/AIDS, as it might raise the risk for development of infection from injections;
• Ongoing treatment with systemic corticosteroids or immunosuppressant medications, as they may block a potential immune mechanism of the PrT and increase the risk for infection;
• Active diagnosis of malignancy anywhere in the body, given potential of any concurrent immune dysfunction to impact on the response to PrT;
• Treatment with any anticoagulant medication beyond 1 aspirin per day, given the potential to increase bleeding or bruising associated with injections;
• Presence of a coagulopathy, given the potential to increase bleeding or bruising associated with injections;
• Pregnancy-as there is no research documenting safety of PrT during pregnancy;
• Medical necessity for taking ongoing nonsteroidal anti-inflammatory medication, beyond 1 aspirin per day for cardiac prevention, as this may diminish the effect of PrT;
• Corticosteroid injection within the 6 weeks prior to entry into the study, as this may diminish the effect of the PrT.
• Prior treatment with PrT for any condition, as this may impact on blinding.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Center for Integrative Medicine at UPMC Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Prolotherapy

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Ronald Glick, MD
• Organization: University of Pittsburgh School of Medicine Department of Psychiatry

glickrm@upmc.edu

412-623-3023

Study Officials

• Ronald M Glick, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 8, 2008
• Study Start: September 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2011
• Last Updated: May 16, 2016
• Results First Posted: May 16, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)